1. Field of the Invention
The invention generally relates to a kit for cell sampling for personal use. In particular, the invention provides a kit for obtaining and shipping personal cell samples.
2. Background of the Invention
In the wake of spectacular advances in molecular and cell biology, which include such feats as the completion of the first sequencing of a human genome, much interest has been generated in applying the acquired knowledge to the treatment of disease conditions. Examples of potential applications include the use of gene therapy to cure diseases, and the use of cells to grow replacement tissue or organs. In particular, the capability now exists to determine the precise sequence of an individual's DNA, opening the possibility of the development of “tailor made” DNA- and/or cell-based therapies for an individual. Such individualized procedures could eliminate certain risk factors such as the rejection of cells or cellular components originating from a non-self donor. Unfortunately, therapies of this type are by and large still in the early stages of development and it may well be many years before they are readily accessible.
Many conditions which may eventually be amenable to treatment in this manner are associated with or develop with advancing age. Further, it is well known that genetic material itself ages and undergoes changes during an individual's lifetime. Thus, in general, cells harvested from an aging individual are less robust than those from the same individual at an earlier age. This observation has prompted the creation of facilities designed for the long-term storage of cells. In particular, cells can be harvested from an individual relatively early in life in the expectation that, as technology advances or as the need arises, the cells can be revived for use in the same individual for a gene- or cell-based therapy. In order to make such a possibility available to large segments of the population, it is necessary to have facile, inexpensive methods for harvesting suitable cells. It is particularly useful to have techniques available that can be carried out by the individuals themselves without any specialized training, and that provide a viable, sterile sample of suitable cells for preservation.
One such method is provided by the previously known Personal Gene Sampling (PGS) cell harvesting kit. The kit, which is available by mail, provides a sterile work surface (a small medical drape) sterile collection swabs, and sterile sample transport tubes for receiving the swabs after a sample has been obtained, as well as a transport bag for containing the transport tubes for shipment to a cryo-preservation facility. A sample-collection surface is located at one end of the collection swab and is formed by positioning suitable absorbent material at that end of the swab. The cell source (e.g. the inside of the cheek) is contacted directly with sample-collecting surface of the swab, for example, by wiping the surface across the cell source. Cells from the source adhere to the sample-collection surface and are removed and transported (for example, by mail) to a cryo-facility.
The sample transport tubes have the feature of containing a plug of material saturated is with media and movably positioned near the top of the tube. Upon insertion of a collection swab into the tube, the sample-collection end of the swab contacts the saturated plug and causes the plug to move further down into the tube. The plug is fitted in the tube and will slide into the tube only as far as it is pushed by the swab. Therefore, upon completion of insertion of the swab, contact is maintained between the collection end of the swab and the saturated plug, thus exposing the cells on the collection surface to the media in the plug. The media previously suggested for use in the kit is Lebovitz's 15 (L-15) media, supplemented with antibiotic and antimycotic reagents.
However, locating the saturated media plug near the mouth of the transport tube provides a ready route of contamination as soon as the tube is opened for use. Further, the use of a media saturated plug means that the shelf-life of the kit is only as long as that of the liquid media. Liquid media is well-known to be readily prone to contamination, and to decomposition during storage.
The prior art has thus far failed to provide a personal cell-sampling kit that overcomes these disadvantages.